510(k) K894103
K894103 is an FDA 510(k) premarket notification submitted by Scimed Life Systems, Inc. for the device "SCIMED ULTROX TRUE MEMBRANE OXYGEN SYST, ULTROX II". The FDA issued a decision of Substantially Equivalent on Sep 21, 1989. The device falls under product code DTZ (Oxygenator, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4350. Scimed Life Systems, Inc. has 108 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Sep 21, 1989
- Date Received
- Jun 9, 1989
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Oxygenator, Cardiopulmonary Bypass
- Device Class
- Class II
- Regulation Number
- 870.4350
- Review Panel
- CV
- Submission Type
- 510(k)